Medical Devices

We design and conduct our studies based on the “Draft Guidance for Industry and Food and Drug Administration Staff:  Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 22, 2011.”

Concentrics has worked with a variety of Class 1 and Class 2 medical devices.  We have conducted hundreds of studies in the following therapeutic areas:

Therapeutic Areas

Respiratory

  • inhalers, nebulizers

Woman’s Health

  • tampons, pads

Baby supplies

  • diapers

Dermatology

  • acne
  • hair removal

Chemical Dependence

  • home testing kits

Endocrinology 

  • insulin injectors

 

 Ophthalmology

  • contact lenses

Pain devices 

  • patches
  • bandages

Cardiovascular 

  • blood pressure devices
  • home defibrillators

Oral Healthcare 

  • whitening strips
  • tooth brushes
  • denture care

 

 

CDRH FDA Interactions

Concentrics has excellent working relationships with key leaders in the Center for Devices and Radiologic Health (CDRH).  We have worked in a number of therapeutic areas and with varying types of studies for Class 1 and 2 devices, including consumer health products.

 Types of Studies

Concentrics has conducted the following types of device studies:

  • Claims Studies
    • Marketing or clinical claims
    • Superiority
    • Parity
    • Non-inferiority
  • Human Factors
  • FMEA (Failure Modes and Effects Analysis) Testing
  • Usability Testing
  • Simulation Studies
  • Validation Testing